Perrigo Company’s subsidiary HRA Pharma is seeking approval for what would be the first over-the-counter (OTC) birth control pill on the market in the U.S.
The Dublin-based maker of self-care products said Monday, July 11, its subsidiary HRA Pharma submitted its application to the U.S. Food and Drug Administration (FDA) for an Rx-to-OTC switch for Opill, a progestin-only daily birth control pill, also referred to as a mini pill or non-estrogen pill.
If approved, this would be the first daily birth control pill available OTC without a prescription in the U.S.
“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.,” said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma. “More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers.”
Almost half of the more than 6.1 million pregnancies in the U.S. each year are unintended, according to the New England Journal of Medicine. Access to a range of methods and ways to access contraception that meet people’s needs will increase the likelihood of using effective birth control methods, HRA Pharma said.
Major medical organizations, including the American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians, said they support moving birth control pills OTC.
Opill consists of 0.075 milligrams of norgestrel and has been used to prevent pregnancy in millions of women in the U.S. since it was FDA approved in 1973. Nearly 50 years of use and scientific evidence show that progestin-only pills like Opill are effective at preventing pregnancy and are safe for most women to use, according to research from the American College of Obstetricians and Gynecologists. As a daily regular contraceptive, Opill is to be used pre-conception to be effective at preventing pregnancy, HRA Pharma said.
Nearly one-third of adult U.S. women who have ever tried to obtain a prescription or refill for contraceptive pill, patch or ring reported difficulties doing so, according to the National Library of Medicine.